UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS Criminal No. UNITED STATES OF AMERICA, 21 U.S.C. §§ 331(a), 333(a)(2) and 352 (Introduction into Interstate Commerce of a Misbranded Drug) ve PHARMACIA & UPJOHN COMPANY, INC. Defendant. SSF INFORMATIO! The United States Attomey charges that: GENERAL ALLEGATIONS tall times material to this Information, unless otherwise alleged: 1, PHARMACIA & UPJOHN COMPANY, INC. (hereinafter “PHARMACIA INC.”) was a Delaware corporation with a principal place of business in Kalamazoo, Michigan. PHARMACIA INC. was a wholly owned subsidiary of Pharmacia & Upjohn LLC, the successor to Pharmacia & Upjohn Company, which was a successor of Pharmacia Corporation, all of which were acquired in April 2003 by Pfizer Inc (all of these entities and their subsidiaries hereinafter collectively “PHARMACTA”). During the relevant time frame, PHARMACIA developed, manufactured, distributed and sold pharmaceutical products nationwide and in the District of Massachusetts. 2. Prior to the April 2003 acquisition, Pharmacia Corporation and its subsidiaries, including PHARMACIA INC,, jointly promoted the drug Bextra with Pfizer Ine, Since April 2003, Pharmacia Corporation and Pharmacia Inc. have been wholly owned subsidiaries of Pfizer Inc.3. PHARMACIA INC. holds the United States trademarks and patents for the drug Bextra, which was distributed from Puerto Rico into interstate commerce throughout the United States, including specifically into Massachusetts, from in or about February 2002 until approximately April 2005, The FDA and the FDCA 4, The United States Food and Drug Administration (“FDA”) was the federal agency of the United States responsible for protecting the health and safety of the public by enforcing the Federal Food, Drug and Cosmetic Act, (“FDCA”), 21 United States Code, Section 301, et seq., and ensuring, among other things, that drugs intended for use in humans were safe and effective for cach of their intended uses and that the labeling of such drugs bore true and accurate information. 5. The FDCA, and its implementing regulations, required that, with certain. exceptions not relevant here, before a new drug could legally be introduced into interstate commerce, a sponsor of a new drug submit and obtain approval of a New Drug Application (“NDA”) from the FDA. 6. The FDCA required that the NDA include proposed labeling for the proposed intended uses of the drug which included, among other things, the conditions for therapeutic use. ‘The NDA was also required to contain, to the satisfaction of FDA, data generated in adequate and well-controlled clinical trials that demonstrated that the drug would be safe and effective when used in accordance with the proposed labeling. 7. AnNDA sponsor was not permitted to promote and market a new drug until it had an approved NDA, including approval for the proposed labeling. Moreover, if approved, thesponsor was permitted to promote and market the drug only for the medical conditions of use and dosages specified in the approved labeling. Uses not approved by the FDA, including dosages not approved in the drug’s approved labeling, were known as “unapproved” or “off-label” uses. 8 The FDCA, and its implementing regulations, required the sponsor to file a Supplemental NDA (“sNDA”), in order to label or promote a drug for uses and dosages different from the conditions for use and dosage specified in the approved labeling. The sNDA was required to include a description of the newly proposed indications for use, and evidence consisting of well-controlled clinical studies, sufficient to demonstrate that the drug was safe and effective for the new use or uses. Only upon FDA approval of the sNDA could the sponsor promote the drug for the new intended use. 9. The FDCA provided that, unless otherwise exempted, a drug was misbranded if, among other things, the labeling did not contain adequate directions for use. 21 U.S.C. § 352(0(1). Adequate directions for use could not be written for medical indications or uses for which the drug had not been approved and proven to be safe and effective through well- controlled clinical studies because unapproved uses could not be included in the labeling, Drugs that were promoted for uses that had not been approved by the FDA were deemed to be misbranded under Section 352(f)(1). 10, The FDCA prohibited the delivery for introduction and causing the delivery for introduction into interstate commerce of a misbranded drug. The Bextra Approval Process 11, Bextra was PHARMACIA’ trade name for the drug valdecoxib that was a so- called “Cox-2 Inhibitor.” At the time Bextra first came on the market in February 2002, the